FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2884464
·
Received December 22, 2012
Report
- Report Number
- 3004209178-2012-91556
- Event Type
- Malfunction
- Date Received
- December 22, 2012
- Date of Event
- November 3, 2012
- Report Date
- December 13, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. HOWEVER, THE DISPLACEMENT TEST PASSED. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARM. THE DEVICE WAS RECEIVED WITH MISSING END CAP STICKER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR SEVERAL TIMES DURING BOLUS DELIVERY. THE BLOOD GLUCOSE READING WAS 363MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT AND SELF TEST AND THEY PASSED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |